ObesityNCT02148770
The Effect of Neurofeedback on Eating Behaviour
A study testing Neurofeedback in people with Obesity and Eating Behaviour, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Neuroimaging is becoming increasingly common to investigate the neural networks underlying eating behaviour and food preference in normal-weight and obese humans. It has been observed that obese in comparison to lean individuals display altered activation patterns in networks of brain areas involved in reward, emotion… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Eating Behaviour
- What is being tested?
- Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects
- Age 18-65 years at start of the study
- Body Mass Index (BMI) between 25 and 40 kg/m2
- Informed consent to study protocol
- Willingness to be informed about chance findings of pathology and approval of the disclosure of this information to the general physician (see Informed Consent)
- Fulfilment of the criteria for blood donors according to the "Richtlinien zur Gewinnung von Blut und Blutbestandteilen und zur Anwendung von Blutprodukten", in particular Hb ≥ 135 g/l (8,37 mmol/l; Bundesärztekammer 2010)
Who cannot join
- Subjects who have a non-removable metal object in or at their body, such as, for ex-ample:
- Heart pace-maker
- Artificial heart valve
- Metal prosthesis
- Metallic implants (screws, plates from operations, etc.)
- Metal splinters / grenade fragments
Show all 24Show fewer
- Non-removable dental braces
- Acupuncture needles
- Insulin pump
- Intraport, etc.
- In field strengths of over 1.0 T also: tattoos, eye lid-shadow
- Current weight loss regimens
- Limited temperature perception and/or increased sensitivity to warming of the body
- Pathological hearing ability or an increased sensitivity to loud noises
- Claustrophobia
- Lack of ability to give informed consent
- Operation less than three month ago
- Simultaneous participation in other studies
- Acute illness or infection during the last 4 weeks
- Neurological disorder or injury
- Moderate or severe head injury
- Severe psychotic illness
- Intake of antidepressants / antipsychotics
- Participation in other studies with blood withdrawals or blood donation in previous and subsequent 2 months
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
UKT and MPI
Tübingen, 72076
Manfred Hallschmid, PhD, +49 7071 29-8825, Manfred.Hallschmid@uni-tuebingen.de
Maartje Spetter, PhD
About this study
Official title: Modulating Functional Connectivity Between Eating-related Brain Areas by Neurofeedback
Neuroimaging is becoming increasingly common to investigate the neural networks underlying eating behaviour and food preference in normal-weight and obese humans. It has been observed that obese in comparison to lean individuals display altered activation patterns in networks of brain areas involved in reward, emotion and cognitive control. Interestingly, obese individuals who are capable of losing weight appear to have a stronger connectivity between areas related to food value and to the control of eating behaviour. The same areas are also associated with healthy food choices. It has been suggested that activation in the prefrontal control areas indirectly modulate valuation-related activity. Based on this, brain-related intervention strategies to support weight loss and long-lasting weight maintenance are of particular interest. Hence, we first want to examine the effect on eating behaviour of neurofeedback training-induced up-regulation of functional connectivity between reward- and impulse-related brain areas as a pilot, and second we want to examine up-regulation of the activity of prefrontal control brain areas.
Read the detailed description
Primary objective: We want to investigate whether the training-induced up-regulation of the dorsal prefrontal cortex inhibits eating behaviour.
Study design: A parallel design. Half of the participants will learn to up-regulate activity of the dorsolateral prefrontal cortex (dlPFC), while the other participants will participate in sham-training sessions. Adherence to experimental conditions will be assigned randomly, based on the participants' enrolment in the study, balanced by gender and binge eating classification.
Study population: 50 overweight and obese (BMI 25-40 kg/m2), but otherwise healthy individuals, 18-65 years old.
Intervention: All participants will participate in a screening day, followed by one neurofeedback session day and a follow-up day. During the neurofeedback session, participants will undergo a 45 min real-time-fMRI-brain-computer-interface scan in order to learn to up-regulate dlPFC activation.
Main study parameters/endpoints:
- The ability to up-regulate dlPFC activity.
- Respective effects on eating behaviour. Nature and extent of the burden and risks associated with participation: Participants will be scanned once (fMRI). Functional MRI is a safe and non-invasive technique.
- Conditions
- Obesity, Eating Behaviour
- Being tested
- Neurofeedback
- Keywords
- rt-fmri, self-control, eating behaviour, overweight, neurofeedback
- Medical subject headings
- Obesity, Feeding Behavior, Self-Control, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackDevice
Also called fMRI-based Brain Computer Interface (BCI), Neurofeedback training, rtfMRI
Networks involved in eating behaviour can be modified by neurofeedback training. We will perform a neurofeedback task using the technology of fMRI-based Brain Computer Interface (BCI). BCI approaches based on real-time fMRI (rtfMRI) allow voluntary regulation of brain regions. For the rtfMRI, a well-established setup will be used which translates the blood oxygen level dependent (BOLD) signal of a specific brain region of interest into a visual signal (e.g. moving bar) in real time using brain voyager® and matlab. The study will include 1 training-sessions In the up-regulation condition subjects will learn to up regulate their dlPFC. In the sham-condition subjects are get the same instructions, however they will receive sham feedback.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Neurofeedback training: Up-regulation of DLPFC. Receives: Device: Neurofeedback |
| Neurofeedback SHAM | Sham comparator | Neurofeedback training: Sham-regulation of DLPFC. Receives: Device: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity in the dlPFC during the training-session
Differences in dlPFC activity between baseline and after up-regulation during the neurofeedback training session, as well as the difference between the treatment and the sham groups (ANCOVA approach).
Measured: 1 day
Secondary outcomes (3)
Food intake
Snack consumption during the snack test, comparing pre vs post neurofeedback session, and between the two groups (ANCOVA approach).
Measured: 4 weeks
Preferred food (healthy or unhealthy food).
Differences in food choice (healthy vs unhealthy) pre compared to post neurofeedback session and between the two groups (ANCOVA approach).
Measured: 4 weeks
Weight
Difference in weight before and after training
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manfred Hallschmid, PhD, Principal investigator, University Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148770
- Sponsor's protocol ID
- 646/2013BO2
- Status last verified
- Jun 2015
- First submitted
- 14 May 2014
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will share the data inside the EU-consortium
Publications
Weiskopf N, Scharnowski F, Veit R, Goebel R, Birbaumer N, Mathiak K. Self-regulation of local brain activity using real-time functional magnetic resonance imaging (fMRI). J Physiol Paris. 2004 Jul-Nov;98(4-6):357-73. doi: 10.1016/j.jphysparis.2005.09.019. Epub 2005 Nov 10.
PubMed 16289548Sitaram R, Caria A, Veit R, Gaber T, Rota G, Kuebler A, Birbaumer N. FMRI brain-computer interface: a tool for neuroscientific research and treatment. Comput Intell Neurosci. 2007;2007:25487. doi: 10.1155/2007/25487.
PubMed 18274615Spetter MS, Malekshahi R, Birbaumer N, Luhrs M, van der Veer AH, Scheffler K, Spuckti S, Preissl H, Veit R, Hallschmid M. Volitional regulation of brain responses to food stimuli in overweight and obese subjects: A real-time fMRI feedback study. Appetite. 2017 May 1;112:188-195. doi: 10.1016/j.appet.2017.01.032. Epub 2017 Jan 25.
PubMed 28131758
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Functional Connectivity Between Eating-related Brain Areas by Neurofeedback
- ClinicalTrials.gov ID
- NCT02148770
- Acronym / sponsor ID
- 646/2013BO2
- Conditions
- Obesity, Eating Behaviour
- Keywords
- rt-fmri, self-control, eating behaviour, overweight, neurofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuroimaging is becoming increasingly common to investigate the neural networks underlying eating behaviour and food preference in normal-weight and obese humans. It has been observed that obese in comparison to lean individuals display altered activation patterns in networks of brain areas involved in reward, emotion and cognitive control. Interestingly, obese individuals who are capable of losing weight appear to have a stronger connectivity between areas related to food value and to the control of eating behaviour. The same areas are also associated with healthy food choices. It has been suggested that activation in the prefrontal control areas indirectly modulate valuation-related activity. Based on this, brain-related intervention strategies to support weight loss and long-lasting weight maintenance are of particular interest. Hence, we first want to examine the effect on eating behaviour of neurofeedback training-induced up-regulation of functional connectivity between reward- and impulse-related brain areas as a pilot, and second we want to examine up-regulation of the activity of prefrontal control brain areas.
Detailed description
Primary objective: We want to investigate whether the training-induced up-regulation of the dorsal prefrontal cortex inhibits eating behaviour.
Study design: A parallel design. Half of the participants will learn to up-regulate activity of the dorsolateral prefrontal cortex (dlPFC), while the other participants will participate in sham-training sessions. Adherence to experimental conditions will be assigned randomly, based on the participants' enrolment in the study, balanced by gender and binge eating classification.
Study population: 50 overweight and obese (BMI 25-40 kg/m2), but otherwise healthy individuals, 18-65 years old.
Intervention: All participants will participate in a screening day, followed by one neurofeedback session day and a follow-up day. During the neurofeedback session, participants will undergo a 45 min real-time-fMRI-brain-computer-interface scan in order to learn to up-regulate dlPFC activation.
Main study parameters/endpoints:
- The ability to up-regulate dlPFC activity.
- Respective effects on eating behaviour. Nature and extent of the burden and risks associated with participation: Participants will be scanned once (fMRI). Functional MRI is a safe and non-invasive technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Device: NeurofeedbackNeurofeedback training: Up-regulation of DLPFC. |
| Neurofeedback SHAM | Sham comparator | Device: NeurofeedbackNeurofeedback training: Sham-regulation of DLPFC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male and female subjects
- Age 18-65 years at start of the study
- Body Mass Index (BMI) between 25 and 40 kg/m2
- Informed consent to study protocol
- Willingness to be informed about chance findings of pathology and approval of the disclosure of this information to the general physician (see Informed Consent)
Key exclusion criteria (24 listed)
- Subjects who have a non-removable metal object in or at their body, such as, for ex-ample:
- Current weight loss regimens
- Limited temperature perception and/or increased sensitivity to warming of the body
- Pathological hearing ability or an increased sensitivity to loud noises
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackAlso: fMRI-based Brain Computer Interface (BCI), Neurofeedback training, rtfMRINetworks involved in eating behaviour can be modified by neurofeedback training. We will perform a neurofeedback task using the technology of fMRI-based Brain Computer Interface (BCI). BCI approaches based on real-time fMRI (rtfMRI) allow voluntary regulation of brain regions. For the rtfMRI, a well-established setup will be used which translates the blood oxygen level dependent (BOLD) signal of a specific brain region of interest into a visual signal (e.g. moving bar) in real time using brain voyager® and matlab. The study will include 1 training-sessions In the up-regulation condition subjects will learn to up regulate their dlPFC. In the sham-condition subjects are get the same instructions, however they will receive sham feedback. | Device | Neurofeedback, Neurofeedback SHAM |
Primary outcome
Activity in the dlPFC during the training-session
Time frame: 1 day
Differences in dlPFC activity between baseline and after up-regulation during the neurofeedback training session, as well as the difference between the treatment and the sham groups (ANCOVA approach).
3 secondary outcomes
Food intake
Time frame: 4 weeks
Preferred food (healthy or unhealthy food).
Time frame: 4 weeks
Weight
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Background: PubMed 16289548Weiskopf N, Scharnowski F, Veit R, Goebel R, Birbaumer N, Mathiak K. Self-regulation of local brain activity using real-time functional magnetic resonance imaging (fMRI). J Physiol Paris. 2004 Jul-Nov;98(4-6):357-73. doi: 10.1016/j.jphysparis.2005.09.019. Epub 2005 Nov 10.
- Background: PubMed 18274615Sitaram R, Caria A, Veit R, Gaber T, Rota G, Kuebler A, Birbaumer N. FMRI brain-computer interface: a tool for neuroscientific research and treatment. Comput Intell Neurosci. 2007;2007:25487. doi: 10.1155/2007/25487.
- Derived from this study: PubMed 28131758Spetter MS, Malekshahi R, Birbaumer N, Luhrs M, van der Veer AH, Scheffler K, Spuckti S, Preissl H, Veit R, Hallschmid M. Volitional regulation of brain responses to food stimuli in overweight and obese subjects: A real-time fMRI feedback study. Appetite. 2017 May 1;112:188-195. doi: 10.1016/j.appet.2017.01.032. Epub 2017 Jan 25.
- Overview of main EU-project.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share the data inside the EU-consortium
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Hallschmid, PhD principal investigator
University Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Obesity and Eating Behaviour, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manfred Hallschmid, PhD (+49 7071 29-8825, Manfred.Hallschmid@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity in the dlPFC during the training-session (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148770, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.